FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25609–25632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2018
Straumann BLX Surgical Cassette
K180791 · KCT
Institut Straumann AG
General Hospital · 86d
Cleared Jun 21, 2018
Eclipse II
K180809 · MQB
Carestream Health, Inc.
Radiology · 85d
Cleared Jun 21, 2018
LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
K181085 · GEI
Covidien
General & Plastic Surgery · 57d
Cleared Jun 21, 2018
Pure Vu System
K181437 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 20d
Cleared Jun 20, 2018
Atlas Percussion Adjusting Instrument
K172536 · LXM
Spinalight, Inc.
Physical Medicine · 302d
Cleared Jun 20, 2018
SuperNO2VA Et Device
K173147 · CCK
Revolutionary Medical Devices, Inc.
Anesthesiology · 264d
Cleared Jun 20, 2018
Penumbra System
K180008 · NRY
Penumbra, Inc.
Neurology · 169d
Cleared Jun 20, 2018
Fracture and Correction System
K180377 · HWC
In2bones USA, LLC
Orthopedic · 128d
Cleared Jun 20, 2018
Balanced Knee Revision System - Offset Junction Box
K180743 · JWH
Ortho Development Corporation
Orthopedic · 90d
Cleared Jun 20, 2018
HairMax Laser
K180885 · OAP
Lexington International, LLC
General & Plastic Surgery · 77d
Cleared Jun 20, 2018
Visura Technologies TEECAD System
K180911 · FDS
Visura Technologies, LLC
Radiology · 75d
Cleared Jun 20, 2018
Cartiva SCI Disposable Instrumentation Set
K181348 · QBO
Cartiva, Inc.
Orthopedic · 30d
Cleared Jun 20, 2018
Televere Digital Dental Imaging System
K181358 · MUH
Televere Systems, Inc.
Radiology · 29d
Cleared Jun 20, 2018
Swiss LithoClast Trilogy
K181364 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 28d
Cleared Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
K181368 · NGZ
bioMerieux, Inc.
Microbiology · 28d
Cleared Jun 19, 2018
sterEOS Workstation
K172346 · LLZ
Eos Imaging
Radiology · 320d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Bionime Corporation
Chemistry · 263d
Cleared Jun 19, 2018
SpeedBird Model SB38 Soft Tissue Biopsy Device
K173316 · KNW
Transmed7, LLC
Gastroenterology & Urology · 243d
Cleared Jun 19, 2018
PICOPLUS Laser System
K173700 · GEX
Lutronic Corporation
General & Plastic Surgery · 197d
Cleared Jun 19, 2018
Surgic Pro, Surgic Pro+
K173905 · EBW
Nakanishi, Inc.
Dental · 179d
Cleared Jun 19, 2018
ViSi Mobile Monitoring System
K180472 · MHX
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
Cleared Jun 19, 2018
Neutrogena Light Therapy Acne Mask+
K180847 · OLP
Johnson & Johnson Consumer, Inc.
General & Plastic Surgery · 78d
Cleared Jun 19, 2018
Neutrogena Light Therapy Aging Mask+
K180856 · OHS
Johnson & Johnson Consumer, Inc.
General & Plastic Surgery · 78d